NDA 011722

NOSTRUM LABS INC

FDA Drug Application

Application #011722

Documents

• Letter: 2004-09-07
• Label: 2004-09-07

Application Sponsors

NDA 011722

NOSTRUM LABS INC

Marketing Status

• Discontinued: 002

Application Products

002

TABLET;ORAL

25MG

1

TENUATE

DIETHYLPROPION HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1959-08-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1976-02-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1976-09-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1978-04-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1979-10-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1982-10-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1983-08-03	PRIORITY
LABELING; Labeling	SUPPL	17	AP	1988-06-17
LABELING; Labeling	SUPPL	18	AP	1982-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1983-06-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1984-01-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1984-02-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1986-10-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1988-07-21	PRIORITY
LABELING; Labeling	SUPPL	25	AP	1998-02-02	STANDARD
LABELING; Labeling	SUPPL	27	AP	1999-05-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2000-07-14	PRIORITY
LABELING; Labeling	SUPPL	29	AP	2004-09-03	STANDARD

Submissions Property Types

SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	28	Null	0

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11722
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENUATE","activeIngredients":"DIETHYLPROPION HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"09\/03\/2004","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/11722s029,12546s032lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TENUATE","submission":"DIETHYLPROPION HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2004-09-03
        )

)